Name: Predicase
Price: 199 USD

K-number	K151579
Device name	MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
Applicant	Siemens Medical Solutions USA, Inc.
Product code	LNH
Device class	Class II
Decision date	Sep 29, 2015
Decision	Substantially Equivalent
Regulation	892.1000

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit

Everything you need for a 510(k) submission. Nothing you don't.